Study Protocol for a Cluster, Randomized, Controlled Community Effectiveness Trial of the Early Start Denver Model (ESDM) Compared to Community Early Behavioral Intervention (EBI) in Community Programs serving Young Autistic Children: Partnering for Autism: Learning more to improve Services (PALMS)

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Introduction: Addressing the Need for Effective Early Autism Interventions

 

The increasing prevalence of autism spectrum disorder (ASD) has significantly heightened the demand for evidence-based early interventions. Traditionally, community programs for young autistic children often rely on applied behavior analysis (ABA) methods, which are structured and sometimes lack the developmental sensitivity needed for younger age groups. To address this gap, a study protocol titled “Study Protocol for a Cluster, Randomized, Controlled Community Effectiveness Trial of the Early Start Denver Model (ESDM) Compared to Community Early Behavioral Intervention (EBI) in Community Programs serving Young Autistic Children: Partnering for Autism: Learning more to improve Services (PALMS)” was published in September 2024. This study, registered under ClinicalTrials.gov identifier NCT06005285, sets out to assess the effectiveness of the ESDM approach compared to the standard EBI methods used in community-based settings.

 

Understanding the Early Start Denver Model (ESDM) and Community EBI

 

  • The Early Start Denver Model (ESDM) is a naturalistic developmental behavioral intervention (NDBI) that combines principles from ABA and developmental psychology. It focuses on engaging young autistic children through play-based activities that are responsive to their developmental level, aiming to improve social communication and cognitive skills. ESDM has demonstrated positive outcomes in several controlled studies, making it a promising intervention for young children with autism.
  • Community Early Behavioral Intervention (EBI) includes a range of structured behavioral approaches typically used in community settings. While effective, these approaches can be more rigid, lacking the individualized focus that ESDM offers. The PALMS trial is designed to test whether ESDM’s more naturalistic and adaptive approach could yield better results when applied in real-world community programs compared to the traditional EBI.
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Study Design: A Hybrid Type 1 Cluster-Randomized Controlled Trial

 

The PALMS trial employs a cluster-randomized controlled design, a robust method that allows researchers to evaluate the effectiveness of ESDM in real-world settings. This design includes:

  • Participants: The study involves 100 supervising providers (50 in the ESDM group and 50 in the EBI group). Each supervisor will oversee three families of young autistic children under the age of 5, leading to a total of 300 children. These children will be supported by 200 behavior technicians, who will assist in delivering the interventions.
  • Intervention Groups:
    • ESDM Group: Providers in this group receive specialized training in ESDM. This training equips them to integrate developmental goals into their interactions with children, using a child-centered and play-based approach.
    • EBI Group: Supervisors continue using the community’s existing EBI practices, which often involve structured teaching and behavioral reinforcement strategies.

 

Research Goals and Objectives

 

The primary aim of the PALMS trial is to assess whether ESDM is more effective than EBI in improving social communication and language skills among young autistic children. The study’s objectives are threefold:

  1. To Compare the Effectiveness of ESDM and EBI: The primary outcomes of interest are improvements in the children’s social communication and language abilities, measured at 6 months and again at 12 months.
  2. To Assess Secondary Outcomes: The trial also examines secondary outcomes such as adaptive behavior in children, how well caregivers apply ESDM strategies at home, and the fidelity with which providers adhere to the intervention protocols.
  3. To Identify Mediating Factors: The study explores how child social motivation and caregiver fidelity to the intervention affect outcomes. Understanding these factors can help determine why some children may benefit more from ESDM than others.
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Detailed Methodology: How the Trial is Conducted

 

  • Training and Implementation: Supervisors in the ESDM group undergo training to understand the principles of this model. They are taught to deliver interventions that foster child-led interactions, focusing on joint attention and reciprocal communication. In contrast, EBI supervisors follow their existing routines, which emphasize structured behavioral teaching.
  • Randomization and Clustering: Supervisors are randomly assigned by region to either the ESDM or EBI group. This clustering approach is critical because it allows for comparisons between the two intervention styles while considering regional variations in service delivery.
  • Evaluation at Multiple Time Points: The trial evaluates the impact of interventions at 6 and 12 months. This design ensures that both short-term and longer-term effects of ESDM versus EBI are captured, offering insights into how quickly benefits manifest and how sustainable they are over time.

 

Outcomes and Measures: What the Study Seeks to Understand

 

The PALMS trial utilizes a range of standardized tools and assessments to gauge the impact of the interventions:

  • Primary Outcome Measures:
    • Social Communication: Assessed through direct observation and caregiver reports to evaluate changes in the child’s ability to engage in social interactions.
    • Language Development: Measured through tools like standardized language assessments to determine improvements in both expressive and receptive language skills.
  • Secondary Outcome Measures:
    • Adaptive Behavior: Observed through daily activities to assess how well children adapt to routines and new situations.
    • Caregiver Strategy Use: Caregivers’ ability to implement ESDM techniques outside of formal sessions is assessed to understand how well they can integrate these methods into everyday interactions.
    • Provider Fidelity: Providers’ adherence to the intervention protocols is monitored, ensuring that the strategies are delivered consistently.

 

Exploring the Role of Mediating Variables

 

The study places a significant emphasis on understanding the mediating factors that may influence outcomes:

  • Child Social Motivation: Children’s inherent motivation to engage socially is a key predictor of success in both interventions. The study tests whether differences in social motivation between children influence how they respond to ESDM compared to EBI.
  • Caregiver Fidelity: The degree to which caregivers can consistently apply ESDM strategies is evaluated as a potential mediator of child outcomes. This aspect highlights the importance of caregiver involvement in reinforcing the intervention outside of formal sessions.
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Significance of the PALMS Trial: Bridging the Research-Practice Gap

 

One of the unique aspects of the PALMS trial is its focus on real-world implementation. Many previous studies on ESDM have been conducted in controlled research settings, making it challenging to generalize findings to community programs where many families access services. By evaluating ESDM within the context of community agencies, this study aims to generate insights that can be directly applied to everyday settings.

 

Expected Contributions to the Field of Autism Intervention

 

The results of this trial have the potential to significantly impact how early intervention is approached for young autistic children:

  • Scaling Up High-Quality Interventions: If ESDM proves to be more effective than EBI, it could pave the way for broader adoption of naturalistic developmental models in community programs, ensuring that more families have access to best practices in autism care.
  • Supporting Publicly Funded Services: The study specifically addresses the needs of families who rely on publicly funded intervention services, which often face resource constraints. By demonstrating the feasibility and effectiveness of ESDM in such settings, the trial could help improve the quality of services available to these families.
  • Guiding Policy and Training Programs: The study’s findings on the implementation determinants of ESDM can inform training programs for providers, ensuring that they are equipped to deliver high-quality, child-centered care. This can also guide policymakers in allocating resources to interventions that have the greatest impact on child outcomes.

 

Conclusion: Towards More Effective and Accessible Autism Interventions

 

The PALMS trial represents a critical step towards understanding the effectiveness of the Early Start Denver Model compared to traditional EBI methods in community settings. By focusing on real-world implementation and including a diverse range of participants, the study aims to provide robust evidence that can help improve services for young autistic children. The findings of this trial could reshape the landscape of early intervention, making high-quality, developmentally appropriate services more accessible to those who need them the most.

 

Source:

https://link.springer.com/article/10.1186/s40359-024-02020-0

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